FDA.reportPublic FDA data

Snow Lotus

Primary DI
16936610210229
Brand
Snow Lotus
Company
Beijing Reagent Latex Products Factory
Model
9.5
Device description
Powder free Sterile Latex Surgical Gloves
Published
2021-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012104000SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVESBeijing Reagent Latex Products Co., Ltd.2001-08-21KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936610210229PackageGS150In Commercial Distribution
26936610210226PackageGS18In Commercial Distribution
06936610210222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693661021022916936610210229
2693661021022626936610210226
06936610210222069366102102226936610210222

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653865840
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936610210017Snow LotusXXS2021-09-18
06936610210024Snow LotusXS2021-09-18
06936610210031Snow LotusS2021-09-18
06936610210048Snow LotusM2021-09-18
06936610210055Snow LotusL2021-09-18
06936610210062Snow LotusXL2021-09-18
06936610210079Snow LotusXXS2021-09-18
06936610210086Snow LotusXS2021-09-18
06936610210093Snow LotusS2021-09-18
06936610210109Snow LotusM2021-09-18
06936610210116Snow LotusL2021-09-18
06936610210123Snow LotusXL2021-09-18
06936610210130Snow LotusXXL2021-09-18
06936610210154Snow Lotus62021-09-18
06936610210161Snow Lotus6.52021-09-18
06936610210178Snow Lotus72021-09-18
06936610210185Snow Lotus7.52021-09-18
06936610210192Snow Lotus82021-09-18
06936610210208Snow Lotus8.52021-09-18
06936610210215Snow Lotus92021-09-18

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